November 2003, Vol. 10, No. 4
The Journal of the American Association of Gynecologic Laparoscopists
Long-term Follow-up of Endometrial Ablation by Modified Loop Resection Hugh T. Lefler, Jr., M.D.
Abstract
(J Am Assoc Gynecol Laparosc 10(4):517–520, 2003)
Study Objective. To describe endometrial ablation by rollerbar-loop-rollerbar (RLR) technique and determine the procedure’s long-term results. Design. Prospective observational study (Canadian Task Force classification II-2). Setting. Private gynecology practice. Patients. One hundred seventeen women with menorrhagia not related to malignancy who were not interested in future fertility. Intervention. After performing rollerbar ablation through a short large Graves speculum, loop resection was carried out down to and throughout superficial myometrium. Rollerbar redesiccation of the cornua and supracervical areas of the uterus completed the procedure. Measurements and Main Results. Patients were contacted by telephone or mail 4 to 5 years after RLR and asked to complete a questionnaire to assess their bleeding status, level of satisfaction with the procedure, and whether or not they had undergone hysterectomy. Of 109 patients responding, 60 (55%) were amenorrheic or menopausal with no bleeding, 21 (19%) had spotting, and 17 (16%) had undergone hysterectomy. Eighty-four (79%) were very satisfied. Conclusion. RLR endometrial ablation was associated with a high rate of amenorrhea and substantial long-term patient satisfaction, but the rate of postablation hysterectomy remained significant.
Preoperative Management Patients who were interested in having RLR endometrial ablation were screened for pathology by pelvic examination and assessed for PMS. They all underwent diagnostic office hysteroscopy without anesthesia, but if the cervix was stenotic, gentle pressure on the os with the Dil-Os (Euro-Med, CooperSurgical, Shelton, CT) was used to open it atraumatically. A microhysteroscope was used with carbon dioxide insufflation for cervical and uterine distention to examine the endocervix and uterine cavity. After hysteroscopy, an endometrial sample was obtained with several passes of a Pipelle to rule out hyperplasia or cancer. No preoperative gonadotropin-releasing hormone was administered to inhibit endometrial growth. Ablations were scheduled during the proliferative phase of the cycle. On the day of surgery patients returned to the office for a final evaluation. This included a final question-and-answer session, physical examination, and vaginal ultrasound to check for pelvic pathology not previously exposed by pelvic examination or hysteroscopy, such as the location of myomata in the myometrium. After operative permits were reviewed and signed, patients reported to the surgery center. On admission, patients had blood samples drawn to measure serum sodium and potassium, which were compared with results after surgery.
Since decreased postoperative bleeding may be correlated with a decrease in premenstrual syndrome (PMS),1,2 amenorrhea is the goal for my endometrial ablation procedures. I began using the rollerbar electrode through a widely dilated cervix for endometrial ablation in 1991, and introduced suction curettage preparation of the uterus for ablation to avoid the cost and patient morbidity associated with pharmacologic endometrial preparation.3 In 1993 I modified the procedure to include the loop electrode in addition to the rollerbar electrode (both Richard Wolf Medical Instruments Corp., Vernon Hills, IL). I anticipated that the loop would remove superficial adenomyosis, which could keep a patient from achieving pain-free, PMS-free amenorrhea. Materials and Methods One hundred seventeen consecutive women (mean age 41.3 yrs, range 26–65 yrs) underwent rollerbar-looprollerbar (RLR) endometrial ablation. They had completed childbearing and had menorrhagia not related to malignancy. Women with suspected adenomyosis, polyps, or myomas that did not cause significant obstruction of the uterine cavity were not excluded. Four to 5 years after surgery, 109 (93%) could be contacted to determine long-term outcomes. From private practice in gynecology, Fort Worth, Texas.
Corresponding author Hugh T. Lefler, Jr., M.D., 1700 Mistletoe Boulevard, Fort Worth, TX 76104. Submitted November 25, 2002. Accepted for publication March 10, 2003. Reprinted from the JOURNAL OF THE AMERICAN ASSOCIATION OF GYNECOLOGIC LAPAROSCOPISTS, November 2003, Vol. 10 No. 4 © 2003 The American Association of Gynecologic Laparoscopists. All rights reserved. This work may not be reproduced in any form or by any means without written permission from the AAGL. This includes but is not limited to, the posting of electronic files on the Internet, transferring electronic files to other persons, distributing printed output, and photocopying. To order multiple reprints of an individual article or request authorization to make photocopies, please contact the AAGL.
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Long-term Follow-up of Modified Loop Resection Endometrial Ablation Leffler
Operative Management The patient was placed in stirrups that supported her legs under the knees for comfort, since the procedure was performed with local anesthesia and conscious sedation. A collection drape was taped to the woman’s perineum and inner thighs to funnel uterine effluent irrigation fluid into collection canisters and to prevent irrigation fluid from leaking onto the floor. A paracervical nerve block of vasopressin 20 U and 1% lidocaine 30 ml was injected to provide anesthesia and to help soften the cervix. It was administered just under the cervical mucosa at 4:30 and 7:30 positions to avoid vascular injection and to ensure good circumferential spread of the agents around the cervix. The cervix was then dilated to a 19F tapered Pratt dilator. Suction curettage at 70 cm Hg vacuum pressure was performed for approximately 2 minutes with a disposable Vacurette F-6 mm (Circon, Racine WI) to denude myometrium of its endometrial covering. The cervix was further dilated to a no. 35 to 37 Pratt dilator to facilitate flow of irrigation fluid out of the uterus around the resectoscope as well as through it, thereby maintaining a clear operating field without build-up of intrauterine pressure. This dilation was usually accomplished easily and without cervical laceration, since the 2 minutes required for suction curettage allowed time for the paracervical anesthetic to take full effect. Cold (4° C) 3% sorbitol uterine irrigation fluid was used to maintain a clear operating field by copious gravity flow through the uterus using a standard urology setup. Three-liter bags of irrigation fluid were hung at the head of the operating table beside the intravenous pole, so that it and intravenous fluid were easily monitored by the anesthetist. The irrigation fluid bags were usually hung 4.5 feet above the level of the uterus to provide adequate uterine distention. Raising the bags during surgery increased uterine distention when better exposure of the cavity was necessary. Using a Force 2 Valleylab electrosurgical generator (Valleylab, Boulder, CO) set at 75 W pure coagulation waveform, a resectoscope with a 24F outer sleeve was used through a short large Graves speculum to perform rollerbar ablation. The resecting loop was used at a setting of 140 W pure cut waveform to resect the entire endometrium down to and throughout superficial myometrium. With the cervix brought down near the introitus with a single-tooth tenaculum through the short large Graves speculum, the resectoscope could be put into and taken out of the uterus easily to remove each strip of tissue. To complete the procedure, the rollerbar was used again at 75 W coagulation primarily to redesiccate cornual areas and the supracervical area. The final irrigation fluid deficit, which might represent fluid absorbed by the patient, was determined by the circulating nurse by subtracting the amount of effluent in the collection canisters from the total used from the irrigation bags. Before the patient left the operating room, an intramuscular injection of 150 mg of depo-medroxyprogesterone
acetate was given to suppress proliferation of new endometrium on denuded surfaces of the uterine cavity.4 All patients were discharged the day of the procedure shortly after surgery. They were seen in the office 2 weeks after ablation for an evaluation that included uterine sounding with the Dil-Os to release potential residual hematometria and to help ensure that they would maintain a patent uterine cavity. Results No woman in this series had significant postoperative hyponatremia, bleeding, or other complications associated with ablation. Information regarding the amount of irrigation fluid absorbed during RLR ablation was available for 106 patients (91%). An average of 6700 ml of sorbitol was used to irrigate the uterus (range 3000–13,300 ml). The median amount absorbed was 100 ml (mean ± SD 154 ± 289 ml, range -100–1700 ml; Figure 1). Only two women (1.9%) had fluid deficits over 1000 ml, and neither required other than routine postoperative management. Neither patient had a normal uterus. Patients were contacted by telephone or mail 4 to 5 years later and asked to fill out a questionnaire concerning bleeding; PMS status; whether or not they had undergone hysterectomy and, if so, why; and satisfaction with RLR ablation. Bleeding status was scored as follows: amenorrheaabsence of bleeding (no bleeding or spotting), spotting (panty liners only), hypomenorrhea (less than what would be considered normal flow), normal flow, or menorrhagia (heavy flow). Of the 117 women, 109 (93%) responded (Table 1). Seventeen had undergone hysterectomy, four for recurrent bleeding, seven for pain, and five for a combination of pain and bleeding. The last patient had adenocarcinoma diagnosed from endometrial tissue removed by suction curettage to prepare the uterus for ablation after a negative office biopsy. Hysterectomy was performed shortly after the diagnosis of cancer was made. I performed 9 of the 17 hysterectomies, and pathology reports in all but 2 of these patients revealed myomas, adenomyosis, or both. Data regarding satisfaction with RLR ablation from 107 women are presented in Table 2. Discussion Ablations were designed specifically to enhance efficacy and safety, with special attention to prevention of excess fluid absorption. They were scheduled before the tenth day of the cycle to take advantage of firm myometrium in the proliferative phase and to avoid significant exposure to progesterone and its effect on the Na-K pump that might lead to cerebral edema in the event of excess fluid absorption if the procedure was performed after ovulation.5 Absorption of irrigation fluid remains the most significant complication of loop ablation. Some methods of endometrial ablation and myoma resection require thousands of milliliters of irrigation fluid. Thus the surgeon must
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FIGURE 1. Fluid deficits in endometrial ablation.
exercise meticulous monitoring of this fluid during hysteroscopic loop procedures to ensure safety.6 Although many surgeons ask the circulating nurse to do this, the protocol in this study called for the anesthesia team to take primary responsibility for monitoring. I suggest that circulating nurses not be given this task, since by the nature of their job they may be out of the operating room when significant fluid absorption occurs. Even though fluid collection may occur through the fallopian tubes, which does not appear to be a common problem, and through the peritoneal cavity also as the result of uterine perforation, it is vascular uptake of fluid that is the primary concern during endometrial ablation. Lacerating or cutting blood vessels and overcoming vascular resistance by transmitted irrigation fluid pressure in the uterus appear to be what lead to dangerous absorption. Without special care to prevent cervical laceration with probable concomitant vascular laceration, irrigation fluid absorption might be even more common than it is. The frequency of cervical lacerations of more that 5 mm or completely through the cervix, which would potentially be considered significant, was 22% during routine dilation with Hagar dilators.7 Tapered Pratt dilators rather than rounded Hagar dilators were used in the present study. It takes about twice as much pressure over time to dilate the cervix with Hagar dilators as it does with Pratt dilators,8 and increased pressure may predispose the cervix to laceration or the fundus to perforation.
TABLE 1. Postablation Bleeding Status Bleeding Status
No. (%) of Patients
Amenorrhea Spotting Light flow Normal periods Heavy flow Hysterectomy
60a (55) 21b (19) 5 (5) 4 (4) 2c (2) 17 (16)
aTwenty-five were menopausal. bTwo were menopausal. cOne was menopausal.
TABLE 2. Patient Satisfaction Satisfaction Very satisfied Satisfied Neutral Dissatisfied Very dissatisfied
No. (%) of Patients 84a (79) 6b (6) 6 (6) 8c (7) 3 (3)
aTwenty-six were menopausal with no bleeding. bOne was menopausal with no bleeding. cOne was menopausal with heavy bleeding.
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Long-term Follow-up of Modified Loop Resection Endometrial Ablation Leffler
Patient Satisfaction The RLR endometrial ablation was designed to destroy more endometrium than could be destroyed by the rollerbar only, since amenorrhea translates into greater relief of PMS than spotting (HT Lefler and CF Lefler, unpublished observations, 2002). After 4 to 5 years, 74% of these patients had essentially no flow, and 79% of them were very satisfied with the results. In addition, 26% of women were menopausal and most of them had no bleeding, with a concomitant high degree of satisfaction. Therefore, bringing a patient to menopause without further surgical intervention is a goal in itself, since almost all women who undergo this procedure should be able to take hormone-replacement therapy without bleeding. Although most women did not bleed, it was disturbing that 16% of them required hysterectomy. In 71% of these patients pain was a contributing factor to hysterectomy, suggesting adenomyosis. In another report, the failure rate of endometrial ablation by loop resection was 69.4% in patients with adenomyosis.9 In conclusion, RLR endometrial ablation is associated with a high rate of amenorrhea-absence of bleeding and a high rate of long-term patient satisfaction; however, the rate of postablation hysterectomy was significant. The presence of myomas or adenomyosis may increase the chance a woman will ultimately require hysterectomy and should be taken into consideration when considering patients for endometrial ablation.
strates the need for continuous, reliable monitoring of irrigation fluid during all hysteroscopic procedures that require copious amounts of fluid. Furthermore, if fluid overload does occur, the patient should be observed continuously until diuresis is complete. References 1. Lefler HT Jr, Lefler CF: Origin of premenstrual syndrome: Assessment by endometrial ablation. J Am Assoc Gynecol Laparosc 1:207–212, 1994 2. Loffer, FD: Three-year comparison of thermal balloon and rollerball ablation in treatment of menorrhagia. J Am Assoc Gynecol Laparosc 8:48–54, 2001 3. Lefler HT Jr, Sullivan GH, Hulka JF: Modified endometrial ablation: Electrocoagulation with vasopressin and suction curettage preparation. Obstet Gynecol 77:949–953, 1991 4. Maia H Jr, Calomon LC, Marques D, et al: Administration of medroxyprogesterone acetate after endomyometrial resection. J Am Assoc Gynecol Laparosc 4:195–200, 1997 5. Boyd HR, Stanley C: Sources of error when tracking irrigation fluids during hysteroscopic procedures. J Am Assoc Gynecol Laparosc 7:472–476, 2000 6. Loffer FD, Bradley LD, Brill AI, et al: Hysteroscopic fluid monitoring guidelines. J Am Assoc Gynecol Laparosc 7:167–168, 2000 7. Hulka JF, Higgins G: Trauma to the internal cervical os during dilation for diagnostic curettage. Am J Obstet Gynecol 82:913–919, 1961
Addendum Eight months after the procedures described here had been completed, a patient rapidly absorbed an excessive amount of sorbitol and died. Rollerbar-loop-rollerbar endometrial ablation requires considerable experience on the part of the surgeon and operating room staff to be performed safely. Life-threatening fluid overload can occur even after precautions are taken to prevent it. This case clearly demon-
8. Hulka JF, Lefler HT Jr, Anglone A, et al: A new electronic force monitor to measure factors influencing cervical dilation for vacuum curettage. Am J Obstet Gynecol 120:166–173, 1974 9. Perez-Medina T, Haya J, San Frutos L, et al: Factors influencing long-term outcome of loop endometrial resection. J Am Assoc Gynecol Laparosc 9:272–276, 2002
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